June 25, 1997

Daniel R. Fritz, Counsel
Kaiser Foundation Health Plan, Inc.
One Kaiser Plaza
Oakland, California 94162

Dear Mr. Fritz:

This is in response to your letter of April 25, requesting guidance for a client who had several issues relating to the Occupational Safety and Health Administration (OSHA) Tuberculosis (TB) Enforcement Procedures.

Your first question inquired about the need for negative pressure rooms during high risk procedures, if local exhaust is provided and health care workers are protected with N-95 respirators. A negative pressure room is an optional requirement for sputum induction procedures. The preferred method for cough-inducing procedures is the use of a local exhaust ventilation device such as a booth or special enclosure. After completion of the procedure, the patient should remain in the enclosure until coughing subsides and the ventilation continued until airborne contaminates have been removed. Health care workers would be required to wear respirators in either case.

In response to your second question about the need for precautions when the patient is asked to self-induce a sputum specimen, the same precautions would apply as when a health care worker induces the sputum production. While a patient may be able to produce a sample without additional coughing, this may not always be the case. A "well-ventilated exam room," if under positive pressure, could push these air contaminants beyond the confines of the room and expose other workers.

Your third question asks about the need for an acid-fast bacilli (AFB) isolation room in a facility that meets the "very low risk" or lower criteria, if suspect TB out-patients are present in the facility for diagnostic procedures. If suspect TB out-patients are seen infrequently, a negative pressure room would not be required for procedures like x-rays and other low-risk treatments. Under OSHA's enforcement procedures, it would be permitted to instruct the patient in the proper procedures, to wear a surgical mask, and to wait in areas separate from the other patients. Some diagnostic procedures, such as those mentioned in the previous questions above, could still require either a negative pressure room or a local exhaust enclosure.

I hope this provides the information you needed and clarifies our position on the issues you mentioned. If you have any further questions, you may contact [the Office of Health Enforcement at (202) 693-2190]. Thank you for your interests in safety and health.

Sincerely,

John B. Miles, Jr., Director
[Directorate of Enforcement Programs]

[Corrected 10/22/2004]

April 25, 1997

Mr. John Miles, Director
[Directorate of Enforcment Programs]
U.S. Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue N.W.
Room N-3468
Washington, D.C. 20012

Re: Tuberculosis Enforcement Directive, Our File No. 97-015

Dear Mr. Miles:

I represent Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and the Permanente Medical Groups, known collectively as the Kaiser Permanente Medical Care Program. My client has asked me to seek guidance with respect to several issues arising under the tuberculosis enforcement guidelines issued by federal OSHA. I have set forth the questions posed, along with my tentative conclusions, as follows:

1. "May high risk procedures such as sputum induction be performed in non-negative pressure rooms so long as health care workers are protected with N-95 respirators and the procedure is carried out utilizing effective local exhaust?" It is my understanding that a negative pressure room would not be required so long as respiratory protection and local exhaust were utilized.

2. "Do different requirements apply when a patient is requested to produce a sputum sample without cough-inducing clinical intervention, as opposed to a process of health-care-worker conducted cough-inducing procedures?"

In circumstances in which a patient is able to produce a sputum sample through normal coughing, the patient could be instructed to wear a surgical mask while in public areas of the facility, enter a well-ventilated exam room alone, produce a sample, cease coughing, and redon the mask. A health care worker wearing a NIOSH-approved N-95 respirator could enter the exam room and obtain the sample. In such circumstances, it is my understanding that it would not be necessary to utilize local exhaust or to provide a room with negative pressure or other aspects of an AFB-isolation room. Please advise whether my understanding is correct.

3. "If an outpatient ("ambulatory care") facility meets the "very low risk" or lower criteria pursuant to CDC guidelines, and performs no high risk procedures, and if suspect TB patients are present in the facility solely for the purpose of confirmatory diagnostic procedures such as x-rays, or to receive low-risk treatments such as oral or injectable medications, would the facility be required to maintain an AFB-isolation room?"

It is my understanding that the facility would not be required to maintain an AFB isolation room under these circumstances.

I would very much appreciate an advisory opinion regarding these questions at your earliest convenience. If you wish to discuss these questions with me further prior to responding, or if you have any questions, please do not hesitate to call me. Please respond by Friday, May 16, 1997 if at all possible.

Thank you for your assistance.

Very truly yours,


Daniel R. Fritz
Counsel